BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 336413 · Received June 8, 2001

    Report

    Report Number
    1226348-2001-00109
    Event Type
    Injury
    Date Received
    June 8, 2001
    Report Date
    May 18, 2001
    Manufacturer
    CODMAN & SHURTLEFF, INC./MODOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE VALVE WAS IMPLANTED IN 2000. IT COULD NOT BE REPROGRAMMED AND WAS REPLACED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26470 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC./MODOS S.A. NA PJ5583

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention